X-RepairSL Z021-160SL

GUDID B055021160SL

X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)

SYNTHASOME, INC.

Multi-purpose surgical mesh, synthetic polymer, bioabsorbable
Primary Device IDB055021160SL
NIH Device Record Keyb33adb48-1d80-4f30-af68-7bf9cf246901
Commercial Distribution StatusIn Commercial Distribution
Brand NameX-RepairSL
Version Model NumberZ021-160SL
Catalog NumberZ021-160SL
Company DUNS140697280
Company NameSYNTHASOME, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx
Phone858-490-9400
Emailxxx@xx.xx

Device Dimensions

Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter
Length160 Millimeter
Width6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB055021160SL [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-13

On-Brand Devices [X-RepairSL]

B05502480SLX-RepairSL, bioabsorbable surgical mesh, single-layer, 25mm x 80mm (WxL)
B05502280SLX-RepairSL, Bioabsorbable surgical mesh, single layer, 12mm x 80mm (WxL)
B055021160SLX-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 160mm (WxL)
B055020160SLX‐RepairSL, Bioabsorbable surgical mesh, single‐layer 4mm x 160mm (WxL)
B05502180X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 80mm (WxL)
B05502120X-RepairSL, Bioabsorbable surgical mesh, single-layer 6mm x 20mm (WxL)
B05502080X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 80mm (WxL)
B05502020X-RepairSL, Bioabsorbable surgical mesh, single-layer 4mm x 20mm (WxL)

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